Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a global pharmaceutical company. Our development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines, team of 7,500+ colleagues helps make healthy possible through
Post : Trainee Officer, IPQA
Job Description
• To issue, retrieve & control of Documents
• To comply Good Documentation Practices.
• To perform the role & responsibilities defined as per TMS software.
• Escalation to Superior for major non- conformities timely.
• To participate in Visual Inspector Qualification activities.
• To interact with cross functional teams to achieve organisational goals.
• To participate in media fill activity.
• To give line clearance & in-process control at all stages of manufacturing & Packing.
• To perform sampling of all kind of intermediate samples, finished product & retain samples timely.
• To perform sampling of process validation and cleaning validation sample as and when required.
• To fulfil the sample requirements of external parties/ regulatory submission.
• To withdraw stability samples as per the requirement.
• To perform Control Sample Management activities.
• To perform In process testing and release.
• To perform AQL at visual and packing stage.
• To prepare data trending for CPV.
• To perform validation activities as and when required.
• To follow the work instruction given to him (via verbal communication or through other type of communication media) other than defined in Job Description.
Skill
• In-depth knowledge of cGMP, GLP, and GAMP guidelines.
• Knowledge of ALCOA+ principles for data integrity.
• Handling of electronic batch records (EBR) and quality systems like TrackWise, SAP-QM, etc.
• Proficiency in Deviation, CAPA, Change Control, and Out of Specification (OOS) documentation.
• Understanding of aseptic area classifications
• Oversight of media fills, sterilization processes, and environmental monitoring.
• Line clearance and area clearance before batch start.
• Oversight of visual inspection for particulates and defects in injectables.
Candidate Profile
B.Pharma/ M.Pharma in Pharmaceuticals
Total Experience - 1- 3 Year inexperience in IPQA : Candidates who want to apply for internal jobs, must have completed atleast 1 years within existing role.
Additional Information
Location : Sanand, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Job Identification : 6453
End Date : 10th October 2025
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